Avery Dennison details evolving pharmaceutical labels market

Pharmaceutical labels have not been optimized to stand out on crowded shelves. This critical converting segment is far more functional than its counterparts in other markets, which rely heavily on branding and aesthetics.

Unlike standard label materials , pharmaceutical labels are designed for challenging technical applications. These often include adhesion to small diameter syringes at low temperatures and exposure to chemicals. These labels often involve sterilization processes like autoclave, ethylene oxide gas, and gamma or e-beam radiation, as well.

“In addition to being purpose-built for pharmaceutical applications, pharma labels differ from standard label materials by providing more robust change management,” notes Cory Keller, senior product manager, Pharmaceuticals, Avery Dennison. “In the case of Avery Dennison, we minimize component changes in the pharma label portfolio, and when we do, we provide advance notification (typically 12 months) to facilitate end-user qualification.”

There is also a significant demand for risk management in pharma labeling. Managing risk associated with drug package system approvals and/or changes is of utmost concern for pharmaceutical companies since ensuring the efficacy and safety is the No. 1 priority. 

“Sometimes, changes to label materials will trigger stability testing at the pharmaceutical company, which can take many months,” says Keller. “Avery Dennison is mindful of these unique qualification requirements, which is why we minimize component changes and provide extended change notification when elective changes are made. Additionally Avery Dennison’s ISO 17025 certified analytical lab can be leveraged to support converters and end users to test pharma label materials in real world conditions to provide support data to facilitate packaging qualification testing.”

New trends

There are several important trends to make note of in the pharma labeling realm. For example, light sensitive drugs are a key innovation area for Avery Dennison.

“Exposure to light is an increasing concern with numerous medications due to the potential for photodegradation or other chemical reactions that affect the drug stability (effectiveness),” states Keller. “While this is driven by the growth of biologic drugs, a global market that Grandview Research values between $400 and $600 billion, with projections estimating it to exceed $1 trillion by 2030. Additionally, many synthetic drugs, like the newly introduced oral GLP-1 medications, are also light sensitive.”

To address the growth of light sensitive drug products, Avery Dennison recently introduced a new UV Barrier Label Portfolio, which includes high opacity materials that block over 99% of UV light. This portfolio also features a clear overlamination film with a greater-than 95% UV light blocking feature. 

“These barrier materials help maintain the effectiveness and shelf life of medications that are sensitive to UV light,” comments Keller. “The clear overlamination film provides the added benefit of visual inspection, an important quality step in the manufacturing of many injectable drug products.”

Seeking sustainability

Sustainability is making its mark here, too. While patient safety will always be the No. 1 priority, pharmaceutical companies are starting to adopt sustainable packaging design concepts in new drug launches and redesigns. 

“Early implementation has been focused on secondary packaging, such as moving from plastic to paper trays/inserts,” says Keller. “There is also a movement from single use to multi-dose auto injectors, which will help reduce the number of devices going to landfill.

“With respect to sustainable pharma label materials, Avery Dennison recognizes there is no one-size-fits-all approach,” adds Keller. “Instead, our pharma label portfolio provides a ‘menu’ of options depending on each end user’s specific goals, whether that be using sustainably sourced paper facestocks, recycled content film liners, or adhesives that enable recycling of HDPE bottles – the main plastic resin used for oral solid dose (pill) medications.”

Speed to market

Unlike other segments, change can often be a lengthy process. Bringing a new drug product to market takes on average 10-15 years, with a development cost between $1.3 to $2.8 billion. The Food and Drug Administration’s (FDA) drug review process is designed to ensure drug products are safe and effective, progressing from pre-clinical (animal testing) to multi-phase clinical (human) trials before the submission of a formal New Drug Application (NDA). This process itself can take six months for review.

“The time and cost associated with new drug launches is driven by the fact it’s highly regulated in the US by the FDA,” explains Keller. “What is important to note is the NDA includes a review of the drug itself and the drug packaging system. Therefore, it’s critical that the drug manufacturer have testing/data to support that the packaging, including label materials, do not negatively impact the safety or quality of the drug.”

Avery Dennison supports end users in the NDA process by maintaining a Drug Master File (DMF) with the FDA. The DMF contains detailed formulation information of Avery Dennison’s pharma adhesives, which only the FDA can access when reviewing an end user’s NDA. 

The FDA access to Avery Dennison’s DMF (granted via Letter of Authorization to the end user and FDA) can expedite the NDA review process to help drug companies get new products to market faster.